Myopic Macular Degeneration Clinical Trial
Official title:
A Phase I/II, Open-Label, Prospective Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (MA09-hRPE) Cells in Patients With Geographic Atrophy Secondary to Myopic Macular Degeneration
Pathologic myopia is a major cause of legal blindness worldwide. In myopic macular
degeneration (MMD), there is degeneration of the retinal pigment epithelial (RPE) layer, and
associated photoreceptors, resulting in vision loss. There is currently no standard
treatment for MMD.
Transplantation of intact sheets of RPE and suspensions of isolated individual RPE cells as
well as autologous translocation of RPE cells has been attempted as treatment for AMD. Human
photoreceptors are comprised of two cell types-rods and cones. Both have a close
relationship with the outermost retinal cells, the retinal pigmented epithelium (RPE). The
RPE is located between the choroid and the photoreceptors. The RPE maintains photoreceptor
function by recycling photopigments,delivering, metabolizing and storing vitamin A,
phagocytosing rod photoreceptor outer segments, transporting iron and small molecules
between retina and choroid, maintaining Bruch's membrane and absorbing stray light to allow
better image resolution. In essence, the RPE layer is critical to the function and health of
photoreceptors and the retina as a whole.
Human PRE (hRPE) transplantation may be a viable option for treatment of degenerative
diseases of the retina.
MA09-hRPE cells are fully differentiated human RPE cells derived from embryonic stem cells.
Transplanted hRPE cells prepared by Advanced Cell Technology have been studied in rodent
models of macular degenerative disease. The data suggests that the subretinal injection of
ACT's hRPE cell products rescues, or at least delays, loss of visual function in two animal
models of retinal degenerative diseases.
The main purpose of this study is to evaluate the safety and tolerability of MA09-hRPE
cellular therapy in patients with Myopic Macular Degeneration (MMD). Another objective is to
evaluate potential efficacy endpoints to be used in future studies of RPE cellular therapy.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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